One year after US Food and Drug Administration (FDA) approval of Rayaldee (calcifediol), Miami-based OPKO Health in June 2017 announced new agreements for the drug with several large Medicare Part D (prescription drug coverage) plan sponsors. The drug helps treat secondary hyperparathyroidism (SHPT) in patients with stages 3–4 chronic kidney disease (CKD) and serum total 25-hydroxyvitamin D less than 30 ng/mL.
The FDA in 2017 issued a complete response letter, indicating deficiencies at OPKO’s third-party contract manager, which were corrected. No issues were cited about the safety, efficacy, or labeling of Rayaldee.
According to OPKO, “approximately 68% of all insurers” have access to Rayaldee. The company notes that it is on track to “reach 75% of all insured lives by year end.” The company expects to expand its sales force into certain geographic areas as reimbursement is secured.
“We are particularly pleased to have Rayaldee covered by an increasing number of Medicare Part D plan sponsors as a large percentage of SHPT patients with CKD stage 3 or 4 are Medicare beneficiaries,” noted Phillip Frost, MD, chairman and chief executive officer (CEO) of OPKO. “The additional coverage recognizes the potential benefits of Rayaldee in this patient population and should enhance our commercial efforts as we seek to fill the treatment void for this large unmet medical need.”
